Guia prático do tratamento com omalizumabe para urticária crônica espontânea
Practical guide to omalizumab treatment for chronic spontaneous urticaria
Janaina Michelle Lima Melo; Leila Vieira Borges; Alfeu Tavares França; Gabriela Andrade Dias; Luis Felipe Chiaverini Ensina; Rosana Câmara Agondi; Solange Oliveira Rodrigues Valle; Régis de Albuquerque Campos
Resumo
A urticária crônica é uma doença com grande impacto socioeconômico e na qualidade de vida do indivíduo. O adequado conhecimento de formas de tratamento eficazes e com perfil de segurança satisfatório, assim como dos mecanismos preditores de resposta ao tratamento, são essenciais para que se alcance um controle adequado da doença. O omalizumabe é um anticorpo monoclonal anti-IgE com eficácia reconhecida e bom perfil de segurança no tratamento da urticária crônica. Objetivamos elucidar questões envolvidas no manejo desta medicação, através da revisão em literatura de estudos atuais e com relevância clínica. Foi realizado levantamento de questões importantes e pouco elucidadas, buscando respostas baseadas nestes estudos. Com isso, foram abordados aspectos práticos do tratamento com o omalizumabe, esclarecendo desde os fenótipos dos pacientes e conduta adequada para estas diferentes situações, trazendo possíveis fatores preditores de resposta ao tratamento e contemplando também um novo anticorpo monoclonal anti-IgE no manejo destes pacientes.
Palavras-chave
Abstract
Chronic urticaria is a disease with great socioeconomic impact on people's quality of life. Adequate knowledge of effective treatments with a satisfactory safety profile as well as of the predictive mechanisms of response to treatment are essential for achieving adequate disease control. Omalizumab is an anti-IgE monoclonal antibody with recognized efficacy and a good safety profile in the treatment of chronic urticaria. We aim to elucidate issues involving the management of this medication through a literature review of current studies with clinical relevance. A survey of important and unclear questions was conducted, and the answers were sought in the studies. Thus, practical aspects of omalizumab treatment were addressed, including the phenotypes of patients and appropriate approaches for different situations. Possible predictive factors of response to treatment and a new anti-IgE monoclonal antibody for the management of these patients were also reported.
Keywords
References
1. Zuberbier T, Aberer W, Asero R, Abdul Latiff AH, Baker D, BallmerWeber B, et al. The EAACI/GA(2)LEN/EDF/WAO guideline for the definition, classification, diagnosis and management of urticaria. Allergy. 2018;73(7):1393-414.
2. Hawro T, Ohanyan T, Schoepke N, Metz M, Peveling-Oberhag A, Staubach P, et al. The Urticaria Activity Score-Validity, Reliability, and Responsiveness. J Allergy Clin Immunol Pract. 2018;6(4):1185‑90.e1.
3. Weller K, Siebenhaar F, Hawro T, Altrichter S, Schoepke N, Maurer M. Clinical Measures of Chronic Urticaria. Immunol Allergy Clin North Am. 2017;37(1):35-49.
4. Moestrup K, Ghazanfar MN, Thomsen SF. Patient-reported outcomes (PROs) in chronic urticaria. Int J Dermatol. 2017;56(12):1342-8.
5. Weller K, Groffik A, Church MK, Hawro T, Krause K, Metz M, et al. Development and validation of the Urticaria Control Test: a patientreported outcome instrument for assessing urticaria control. J Allergy Clin Immunol. 2014;133(5):1365-72.
6. Ohanyan T, Schoepke N, Bolukbasi B, Metz M, Hawro T, Zuberbier T, et al. Responsiveness and minimal important difference of the urticaria control test. J Allergy Clin Immunol. 2017;140(6):1710-3.
7. Baiardini I, Braido F, Bindslev-Jensen C, Bousquet PJ, Brzoza Z, Canonica GW, et al. Recommendations for assessing patientreported outcomes and health-related quality of life in patients with urticaria: a GA(2) LEN taskforce position paper. Allergy. 2011;66(7):840-4.
8. Baiardini I, Fasola S, Maurer M, Weller K, Canonica GW, Braido F. Minimal important difference of the Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL). Allergy. 2019;74(12):2542-4.
9. Baiardini I, Pasquali M, Braido F, Fumagalli F, Guerra L, Compalati E, et al. A new tool to evaluate the impact of chronic urticaria on quality of life: chronic urticaria quality of life questionnaire (CU-QoL). Allergy. 2005;60(8):1073-8.
10. Dias GA, Pires GV, Valle SO, Franca AT, Papi JA, Dortas Jr. SD, et al. Cross-cultural adaptation of the Brazilian-Portuguese version of the chronic urticaria quality-of-life questionnaire - CU-Q2oL. Allergy. 2011;66(11):1487-93.
11. Dortas Junior S, Valle S, Weller K, Lupi O, Maurer M. Adaptação transcultural do questionário “Urticaria Control Test” para o português brasileiro. InterScience Place. 2017;12:165-75. Referências
12. Saini SS, Bindslev-Jensen C, Maurer M, Grob JJ, Bülbül Baskan E, Bradley MS, et al. Efficacy and safety of omalizumab in patients with chronic idiopathic/spontaneous urticaria who remain symptomatic on h1 antihistamines: a randomized, placebo-controlled study. J Invest Dermatol. 2015;135(3):925.
13. Maurer M, Rosén K, Hsieh HJ, Saini S, Grattan C, Gimenéz-Arnau A, et al. Omalizumab for the treatment of chronic idiopathic or spontaneous urticaria. N Engl J Med. 2013;368(10):924-35.
14. Saini S, Rosen KE, Hsieh HJ, Wong DA, Conner E, Kaplan A, et al. A randomized, placebo-controlled, dose-ranging study of single-dose omalizumab in patients with H1-antihistamine-refractory chronic idiopathic urticaria. J Allergy Clin Immunol. 2011;128(3):567-73.
15. Türk M, Carneiro-Leao L, Kolkhir P, Bonnekoh H, Buttgereit T, Maurer M. How to treat patients with chronic spontaneous urticaria with omalizumab: questions and answers. J Allergy Clin Immunol Pract. 2020;8(1):113-24.
16. Asero R, Tedeschi A. Usefulness of a short course of oral prednisone in antihistamine-resistant chronic urticaria: a retrospective analysis. J Investig Allergol Clin Immunol. 2010;20(5):386-90.
17. Kaplan A, Ledford D, Ashby M, Canvin J, Zazzali JL, Conner E, et al. Omalizumab in patients with symptomatic chronic idiopathic/ spontaneous urticaria despite standard combination therapy. J Allergy Clin Immunol. 2013;132(1):101-9.
18. Gastaminza G, Azofra J, Nunez-Cordoba JM, Baeza ML, Echechipia S, Gaig P, et al. Efficacy and Safety of Omalizumab (Xolair) for Cholinergic Urticaria in Patients Unresponsive to a Double Dose of Antihistamines: A Randomized Mixed Double-Blind and OpenLabel Placebo-Controlled Clinical Trial. J Allergy Clin Immunol Pract. 2019;7(5):1599-609.
19. Maurer M, Metz M, Brehler R, Hillen U, Jakob T, Mahler V, et al. Omalizumab treatment in patients with chronic inducible urticaria: A systematic review of published evidence. J Allergy Clin Immunol. 2018;141(2):638-49.
20. Dressler C, Werner RN, Eisert L, Zuberbier T, Nast A, Maurer M. Chronic inducible urticaria: a systematic review of treatment options. J Allergy Clin Immunol. 2018;141(5):1726-34.
21. Krause K, Ardelean E, Kessler B, Magerl M, Metz M, Siebenhaar F, et al. Antihistamine-resistant urticaria factitia successfully treated with anti-immunoglobulin E therapy. Allergy. 2010;65(11):1494-5.
22. Maurer M, Schütz A, Weller K, Schoepke N, Peveling-Oberhag A, Staubach P, et al. Omalizumab is effective in symptomatic dermographism-results of a randomized placebo-controlled trial. J Allergy Clin Immunol. 2017;140(3):870-3.
23. Metz M, Schütz A, Weller K, Gorczyza M, Zimmer S, Staubach P, et al. Omalizumab is effective in cold urticaria-results of a randomized placebo-controlled trial. J Allergy Clin Immunol. 2017;140(3):864-7.
24. Krause K, Zuberbier T, Maurer M. Modern approaches to the diagnosis and treatment of cold contact urticaria. Curr Allergy Asthma Rep. 2010;10(4):243-9.
25. Boyce JA. Successful treatment of cold-induced urticaria/anaphylaxis with anti-IgE. J Allergy Clin Immunol. 2006;117(6):1415-8.
26. Güzelbey O, Ardelean E, Magerl M, Zuberbier T, Maurer M, Metz M. Successful treatment of solar urticaria with anti-immunoglobulin E therapy. Allergy. 2008;63(11):1563-5.
27. Zhao ZT, Ji CM, Yu WJ, Meng L, Hawro T, Wei JF, et al. Omalizumab for the treatment of chronic spontaneous urticaria: A metaanalysis of randomized clinical trials. J Allergy Clin Immunol. 2016;137(6):1742‑50.
28. Maurer M, Altrichter S, Bieber T, Biedermann T, Bräutigam M, Seyfried S, et al. Efficacy and safety of omalizumab in patients with chronic urticaria who exhibit IgE against thyroperoxidase. J Allergy Clin Immunol. 2011;128(1):202-9.
29. Ensina LF, Valle SO, Juliani AP, Galeane M, Vieira dos Santos R, Arruda LK, et al. Omalizumab in Chronic Spontaneous Urticaria: A Brazilian Real-Life Experience. Int Arch Allergy Immunol. 2016;169(2):121-4.
30. Rubini NPM, Ensina LFC, Silva EMK, Sano F, Sole D. Effectiveness and safety of Omalizumab in the treatment of chronic spontaneous urticaria: Systematic review and meta-analysis. Allergol Immunopathol (Madr). 2019;47(6):515-22.
31. Tharp MD, Bernstein JA, Kavati A, Ortiz B, MacDonald K, Denhaerynck K, et al. Benefits and Harms of Omalizumab Treatment in Adolescent and Adult Patients With Chronic Idiopathic (Spontaneous) Urticaria: A Meta-analysis of "Real-world" Evidence. JAMA Dermatol. 2019;155(1):29-38.
32. Weller K, Ohanyan T, Hawro T, Ellrich A, Sussman G, Koplowitz J, et al. Total IgE levels are linked to the response of chronic spontaneous urticaria patients to omalizumab. Allergy. 2018;73(12):2406-8.
33. Ertas R, Ozyurt K, Atasoy M, Hawro T, Maurer M. The clinical response to omalizumab in chronic spontaneous urticaria patients is linked to and predicted by IgE levels and their change. Allergy. 2018;73(3):705-12.
34. Deza G, Ricketti PA, Gimenez-Arnau AM, Casale TB. Emerging Biomarkers and Therapeutic Pipelines for Chronic Spontaneous Urticaria. J Allergy Clin Immunol Pract. 2018;6(4):1108-17.
35. Ertas R, Ozyurt K, Ozlu E, Ulas Y, Avci A, Atasoy M, et al. Increased IgE levels are linked to faster relapse in patients with omalizumabdiscontinued chronic spontaneous urticaria. J Allergy Clin Immunol. 2017;140(6):1749-51.
36. Asero R, Marzano AV, Ferrucci S, Genovese G, Cugno M. Baseline D-dimer plasma levels correlate with disease activity but not with the response to omalizumab in chronic spontaneous urticaria. Allergy. 2019;74(12):2538.
37. Ghazanfar MN, Thomsen SF. D-dimer as a potential blood biomarker for disease activity and treatment response in chronic urticaria: a focused review. Eur J Dermatol. 2018;28(6):731-5.
38. Cugno M, Genovese G, Ferrucci S, Casazza G, Asero R, Marzano AV. IgE and D-dimer baseline levels are higher in responders than nonresponders to omalizumab in chronic spontaneous urticaria. Br J Dermatol. 2018;179(3):776-7.
39. Namazy J, Cabana MD, Scheuerle AE, Thorp JM, Chen H, Carrigan G, et al. The Xolair Pregnancy Registry (EXPECT): the safety of omalizumab use during pregnancy. J Allergy Clin Immunol. 2015;135(2):407-12.
40. Ensina LF, Cusato-Ensina AP, Camelo-Nunes IC, Solé D. Omalizumab as Third-Line Therapy for Urticaria During Pregnancy. J Investig Allergol Clin Immunol. 2017;27(5):326-7.
41. Ben-Shoshan M, Grattan CE. Management of Pediatric Urticaria with Review of the Literature on Chronic Spontaneous Urticaria in Children. J Allergy Clin Immunol Pract. 2018;6(4):1152-61.
42. Bernstein JA, Kavati A, Tharp MD, Ortiz B, MacDonald K, Denhaerynck K, et al. Effectiveness of omalizumab in adolescent and adult patients with chronic idiopathic/spontaneous urticaria: a systematic review of 'real-world' evidence. Expert Opin Biol Ther. 2018;18(4):425-48.
43. Ensina LF, Arruda LK, Campos RA, Criado RF, Rodrigues Valle S, Melo JM, et al. H1-Antihistamines May No Longer Be Necessary for Patients With Refractory Chronic Spontaneous Urticaria After Initiation of Omalizumab. J Investig Allergol Clin Immunol. 2020;30(2):145-7.
44. Casale TB, Bernstein JA, Maurer M, Saini SS, Trzaskoma B, Chen H, et al. Similar Efficacy with Omalizumab in Chronic Idiopathic/ Spontaneous Urticaria Despite Different Background Therapy. J Allergy Clin Immunol Pract. 2015;3(5):743-50.
45. Nettis E, Cegolon L, Di Leo E, Lodi Rizzini F, Detoraki A, Canonica GW. Omalizumab in chronic spontaneous urticaria: Efficacy, safety, predictors of treatment outcome, and time to response. Ann Allergy Asthma Immunol. 2018;121(4):474-8.
46. Casale TB, Murphy TR, Holden M, Rajput Y, Yoo B, Bernstein JA. Impact of omalizumab on patient-reported outcomes in chronic idiopathic urticaria: Results from a randomized study (XTEND-CIU). J Allergy Clin Immunol Pract. 2019;7(7):2487-90.
47. Larenas-Linnemann DES, Parisi CAS, Ritchie C, Cardona-Villa R, Cherrez-Ojeda I, Cherrez A, et al. Update on Omalizumab for Urticaria: What's New in the Literature from Mechanisms to Clinic. Curr Allergy Asthma Rep. 2018;18(5):33.
48. Hide M, Igarashi A, Yagami A, Chinuki Y, Inomata N, Fukunaga A, et al. Efficacy and safety of omalizumab for the treatment of refractory chronic spontaneous urticaria in Japanese patients: Subgroup analysis of the phase 3 POLARIS study. Allergol Int. 2018;67(2):243-52.
49. Mandel VD, Guanti MB, Liberati S, Demonte A, Pellacani G, Pepe P. Omalizumab in Chronic Spontaneous Urticaria Refractory to Conventional Therapy: An Italian Retrospective Clinical Analysis with Suggestions for Long-Term Maintenance Strategies. Dermatol Ther (Heidelb). 2018;8(2):291-301.
50. Navarro-Trivino FJ, Merida-Fernandez C, Linares-Gonzalez L, Ruiz-Villaverde R. Is omalizumab safe and effective in oncological patients? Dermatol Ther. 2019:e13115.
51. Long A, Rahmaoui A, Rothman KJ, Guinan E, Eisner M, Bradley MS, et al. Incidence of malignancy in patients with moderate-tosevere asthma treated with or without omalizumab. J Allergy Clin Immunol. 2014;134(3):560-7.
52. Busse W, Buhl R, Fernandez Vidaurre C, Blogg M, Zhu J, Eisner MD, et al. Omalizumab and the risk of malignancy: results from a pooled analysis. J Allergy Clin Immunol. 2012;129(4):983-9.
53. Zuberbier T, Aberer W, Asero R, Bindslev-Jensen C, Brzoza Z, Canonica GW, et al. The EAACI/GA(2) LEN/EDF/WAO Guideline for the definition, classification, diagnosis, and management of urticaria: the 2013 revision and update. Allergy. 2014;69(7):868-87.
54. Weller K, Groffik A, Magerl M, Tohme N, Martus P, Krause K, et al. Development, validation, and initial results of the Angioedema Activity Score. Allergy. 2013;68(9):1185-92.
55. Weller K, Groffik A, Magerl M, Tohme N, Martus P, Krause K, et al. Development and construct validation of the angioedema quality of life questionnaire. Allergy. 2012;67(10):1289-98.
56. Kaplan A, Ferrer M, Bernstein JA, Antonova E, Trzaskoma B, Raimundo K, et al. Timing and duration of omalizumab response in patients with chronic idiopathic/spontaneous urticaria. J Allergy Clin Immunol. 2016;137(2):474-81.
57. Gericke J, Metz M, Ohanyan T, Weller K, Altrichter S, Skov PS, et al. Serum autoreactivity predicts time to response to omalizumab therapy in chronic spontaneous urticaria. J Allergy Clin Immunol. 2017;139(3):1059-61.
58. Metz M, Vadasz Z, Kocatürk E, Giménez-Arnau AM. Omalizumab Updosing in Chronic Spontaneous Urticaria: an Overview of RealWorld Evidence. Clin Rev Allergy Immunol. 2020;59(1):38-45.
59. Aghdam MA, Pieterse RH, Kentie Manp PA, Rijken F, Knulst AC, Röckmann H. Effective omalizumab interval prolongation in the treatment of chronic urticaria. J Allergy Clin Immunol Pract. 2020.
60. Turk M, Kocaturk E, Cure K, Yilmaz I. Two-week intervals during omalizumab treatment may provide better symptom control in selected patients with chronic urticaria. J Allergy Clin Immunol Pract. 2018;6(4):1389-90.
61. Niemeyer-van der Kolk T, van Maaren MS, van Doorn MBA. Personalized omalizumab treatment improves clinical benefit in patients with chronic spontaneous urticaria. J Allergy Clin Immunol. 2018;142(6):1992-4.
62. Curto-Barredo L, Spertino J, Figueras-Nart I, Exposito-Serrano V, Guilabert A, Mele-Ninot G, et al. Omalizumab updosing allows disease activity control in patients with refractory chronic spontaneous urticaria. Br J Dermatol. 2018;179(1):210-2.
63. Maurer M, Kaplan A, Rosen K, Holden M, Iqbal A, Trzaskoma BL, et al. The XTEND-CIU study: Long-term use of omalizumab in chronic idiopathic urticaria. J Allergy Clin Immunol. 2018;141(3):1138-9.
64. Türk M, Yılmaz İ, Bahçecio lu SN. Treatment and retreatment with omalizumab in chronic spontaneous urticaria: Real life experience with twenty-five patients. Allergol Int. 2018;67(1):85-9.
65. Ensina LF, de Lacerda AE, Machado LM, Camelo-Nunes I, Sole D. Long-term omalizumab therapy for refractory chronic spontaneous urticaria: a real-life experience. Ann Allergy Asthma Immunol. 2015;115(6):536.
66. Nettis E, Di Leo E, Foti C, Cegolon L, Vacca A. Efficacy and rapid activity of omalizumab retreatment in chronic spontaneous urticaria. J Am Acad Dermatol. 2018;78(6):1211-3.
67. Metz M, Ohanyan T, Church MK, Maurer M. Retreatment with omalizumab results in rapid remission in chronic spontaneous and inducible urticaria. JAMA Dermatol. 2014;150(3):288-90.
68. Har D, Patel S, Khan DA. Outcomes of using omalizumab for more than 1 year in refractory chronic urticaria. Ann Allergy Asthma Immunol. 2015;115(2):126-9.
69. Ferrer M, Gimenez-Arnau A, Saldana D, Janssens N, Balp MM, Khalil S, et al. Predicting Chronic Spontaneous Urticaria Symptom Return After Omalizumab Treatment Discontinuation: Exploratory Analysis. J Allergy Clin Immunol Pract. 2018;6(4):1191-7.
70. Kolkhir P, Church MK, Altrichter S, Skov PS, Hawro T, Frischbutter S, et al. Eosinopenia, in chronic spontaneous urticaria, is associated with high disease activity, autoimmunity, and poor response to treatment. J Allergy Clin Immunol Pract. 2020 Jan;8(1):318-25.
71. Marzano AV, Genovese G, Casazza G, Fierro MT, Dapavo P, Crimi N, et al. Predictors of response to omalizumab and relapse in chronic spontaneous urticaria: a study of 470 patients. J Eur Acad Dermatol Venereol. 2019;33(5):918-24.
72. Schoepke N, Asero R, Ellrich A, Ferrer M, Gimenez-Arnau A, C EHG, et al. Biomarkers and clinical characteristics of autoimmune chronic spontaneous urticaria: Results of the PURIST Study. Allergy. 2019;74(12):2427-36.
73. Sanchez-Borges M, Capriles-Hulett A, Caballero-Fonseca F, Gonzalez-Aveledo L. Biomarkers of treatment efficacy in patients with chronic spontaneous urticaria. Eur Ann Allergy Clin Immunol. 2018;50(1):5-9.
74. Straesser MD, Oliver E, Palacios T, Kyin T, Patrie J, Borish L, et al. Serum IgE as an immunological marker to predict response to omalizumab treatment in symptomatic chronic urticaria. J Allergy Clin Immunol Pract. 2018;6(4):1386-8.
75. Asero R, Marzano AV, Ferrucci S, Cugno M. Elevated baseline D-dimer plasma levels are associated with a prompt response to omalizumab in patients with severe CSU. J Allergy Clin Immunol Pract. 2017;5(6):1740-2.
76. Stitt JM, Dzieciatkowska M, Edwards MG, Hansen K, Hedlund G, Dreskin SC. The basophil proteome in chronic spontaneous urticaria distinguishes responders to omalizumab from non-responders. Clin Exp Allergy. 2018;48(7):898-901.
77. Deza G, Bertolín-Colilla M, Pujol RM, Curto-Barredo L, Soto D, García M, et al. Basophil FcεRI Expression in Chronic Spontaneous Urticaria: A Potential Immunological Predictor of Response to Omalizumab Therapy. Acta Derm Venereol. 2017;97(6):698-704.
78. Wedi B. Ligelizumab for the treatment of chronic spontaneous urticaria. Expert Opin Biol Ther. 2020;20(8):853-61.
79. Gasser P, Tarchevskaya SS, Guntern P, Brigger D, Ruppli R, Zbären N, et al. The mechanistic and functional profile of the therapeutic anti-IgE antibody ligelizumab differs from omalizumab. Nat Commun. 2020;11(1):165.
80. Maurer M, Gimenez-Arnau AM, Sussman G, Metz M, Baker DR, Bauer A, et al. Ligelizumab for Chronic Spontaneous Urticaria. N Engl J Med. 2019;381(14):1321-32.
Submitted date:
08/20/2020
Accepted date:
08/27/2020
Facebook
Google+
Twitter
LinkedIn
Mendeley
StumbleUpon
CiteULike
Reddit
Email